sigir-20141
GT: not enough information
Included
Обоснование:
- + Patients of chronic stable angina with abnormal Ex... (score: 0.51)
- + Patient must understand and be willing, able and l... (score: 0.77)
- No exclusion criteria met
Inclusion met: 3
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards.
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
inclusion
MET
📋 Критерий
Patient must be able to give voluntary written informed consent.
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
inclusion
MET
📋 Критерий
Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.
🏥 Из анамнеза пациента
"Physical examination is normal."
exclusion
NOT MET
📋 Критерий
Cardiac arrhythmias or II or III degree AV block
🏥 Из анамнеза пациента
"Physical examination is normal."
exclusion
NOT MET
📋 Критерий
Myocardial infarction in < 6 months
🏥 Из анамнеза пациента
"Physical examination is normal."
exclusion
NOT MET
📋 Критерий
Patients not eligible for Tc 99m SPECT
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
exclusion
NOT MET
📋 Критерий
Severe anemia (Hb 7G/dl)
🏥 Из анамнеза пациента
"The pain started while she was walking, radiates to the back, and is accompanied by nausea, diaphoresis and mild dyspnea, but is not increased on inspiration."
exclusion
NOT MET
📋 Критерий
Unstable angina
🏥 Из анамнеза пациента
"Physical examination is normal."
exclusion
NOT MET
📋 Критерий
Hypertension of > 170/100 mm of Hg
🏥 Из анамнеза пациента
"She is known to have hypertension and obesity."
exclusion
NOT MET
📋 Критерий
Geographical inaccessibility for treatment or follow-up evaluations
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
exclusion
NOT MET
📋 Критерий
Pregnant and nursing women
🏥 Из анамнеза пациента
"She currently takes no medications."
exclusion
NOT MET
📋 Критерий
Congestive cardiac failure
🏥 Из анамнеза пациента
"She is known to have hypertension and obesity."
exclusion
NOT MET
📋 Критерий
Patients in whom beta blockers are contraindicated
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
exclusion
NOT MET
📋 Критерий
Known hypersensitivity to nicorandil
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
exclusion
NOT MET
📋 Критерий
Valvular heart disease and cardiomyopathy
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
exclusion
NOT MET
📋 Критерий
IDDM (Type-1 diabetes mellitus)
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
exclusion
NOT MET
📋 Критерий
Significant liver or renal dysfunction
🏥 Из анамнеза пациента
"She is known to have hypertension and obesity."
exclusion
NOT MET
📋 Критерий
On calcium channel blockers
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure < 100 mm Hg
🏥 Из анамнеза пациента
"She denies smoking, diabetes, hypercholesterolemia, or a family history of heart disease."
inclusion
UNKNOWN
📋 Критерий
Age 25 to 65 years
🏥 Из анамнеза пациента
"The latest episode of pain ended half an hour prior to her arrival."
inclusion
UNKNOWN
📋 Критерий
Male and female
🏥 Из анамнеза пациента
"The patient will provide informed consent, and will comply with the trial protocol without any practical issues."
dapa-001
GT: included
Included
Обоснование:
- + Provision of signed informed consent prior to any ... (score: 0.76)
- + Male or female, aged ≥18 years (score: 1.00)
- No exclusion criteria met
Inclusion met: 7
Inclusion not met: 0
Unknown: 0
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 66-year-old man with chronic symptomatic HFrEF for 3 years."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38% on echo 6 weeks ago."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 36 mL/min/1.73 m²."
inclusion
MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Will provide informed consent."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 640 pg/mL (sinus rhythm)."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 66-year-old man with chronic symptomatic HFrEF for 3 years."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 108 mmHg without dizziness."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II, stable for 4 months."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No MI/stroke/revascularization in last 3 months."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 36 mL/min/1.73 m²."
dapa-002
GT: included
Included
Обоснование:
- + Provision of signed informed consent prior to any ... (score: 0.72)
- + Male or female, aged ≥18 years (score: 1.00)
- No exclusion criteria met
Inclusion met: 7
Inclusion not met: 0
Unknown: 0
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old woman with chronic HFrEF due to ischemic cardiomyopathy."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40% documented 1 month ago."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 31."
inclusion
MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Consents to trial."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL (no AF)."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"On guideline-directed HF therapy."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent acute coronary syndrome."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 100 without symptoms of hypotension."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent acute coronary syndrome."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent acute coronary syndrome."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"Consents to trial."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 31."
dapa-003
GT: excluded
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 63-year-old man with nonischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 44."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 590 pg/mL (sinus rhythm)."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No prior SGLT2 inhibitor."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"On ACEi + beta-blocker; MRA planned."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 63-year-old man with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"Stable symptoms."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 44."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Stable symptoms."
dapa-004
GT: not enough information
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + LVEF≤40% (score: 1.00)
- No exclusion criteria met
Inclusion met: 5
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF and intermittent AF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 40."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 880 pg/mL with documented AF at screening."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 35%."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent MI/stroke."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent MI/stroke."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 106."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 40."
inclusion
UNKNOWN
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 35%."
dapa-007
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.51)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 32."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,200 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No prior SGLT2 inhibitor."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 98 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 74-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 33%."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 32."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"On full GDMT."
dapa-009
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 47."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 102."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 34%."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 47."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 34%."
dapa-011
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.48)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 34."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,800 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 116."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 34."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
dapa-012
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 30 exactly on repeat labs."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 30 exactly on repeat labs."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 39%."
dapa-014
GT: not enough information
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.55)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 61-year-old man with HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 42."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL with AF documented on ECG."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 61-year-old man with HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 105."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 42."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 40%."
dapa-016
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 58-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 70."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 37%."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 58-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 58-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 70."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 37%."
dapa-017
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 35."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 605 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 96."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 38%."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 35."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 38%."
dapa-018
GT: excluded
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 65-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 37."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 575 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 65-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 109."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 37."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 109."
dapa-019
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.54)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 33."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,500 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 95 without symptoms."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"SBP 95 without symptoms."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"A 72-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 33."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 95 without symptoms."
dapa-021
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.55)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 41."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"T2DM controlled, no SGLT2 use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"T2DM controlled, no SGLT2 use."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 36%."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 104."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 41."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 36%."
dapa-022
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 71-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 31."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 71-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No SGLT2 use."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"Recent hospitalization for HF 10 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 31."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 38%."
dapa-024
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 62-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 59."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 660 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 62-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 59."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No recent CV events."
dapa-026
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 48."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 690 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 99."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 38%."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 48."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 38%."
dapa-027
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.51)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 75-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 30."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 75-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"LVEF 32%."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 96 without symptoms."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"SBP 96 without symptoms."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 32%."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"LVEF 32%."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 30."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 96 without symptoms."
dapa-028
GT: not enough information
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 46."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP not available in records."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 64-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 114."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 46."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"NT-proBNP not available in records."
dapa-029
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 61-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 51."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 61-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No diabetes."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 107."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 51."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No SGLT2 use."
dapa-030
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.55)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 34."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 605 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 95 with no orthostatic symptoms."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 exposure."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 exposure."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 34."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 40%."
dapa-031
GT: included
Included
Обоснование:
- + Provision of signed informed consent prior to any ... (score: 0.76)
- + Male or female, aged ≥18 years (score: 1.00)
- No exclusion criteria met
Inclusion met: 7
Inclusion not met: 0
Unknown: 0
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40% on echocardiography 4 weeks ago."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 33 mL/min/1.73 m²."
inclusion
MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Will provide informed consent."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II, clinically stable for 5 months."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 97 mmHg without dizziness."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"LVEF 40% on echocardiography 4 weeks ago."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II, clinically stable for 5 months."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II, clinically stable for 5 months."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No MI/unstable angina/stroke/TIA or revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 33 mL/min/1.73 m²."
dapa-032
GT: excluded
Included
Обоснование:
- + Provision of signed informed consent prior to any ... (score: 0.72)
- + Male or female, aged ≥18 years (score: 1.00)
- No exclusion criteria met
Inclusion met: 7
Inclusion not met: 0
Unknown: 0
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 40% on recent echo."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 34."
inclusion
MET
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Consents to participation."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 590 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II, stable."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF for 3 years."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 99 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II, stable."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"LVEF 40% on recent echo."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II, stable."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 34."
dapa-033
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.51)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 41."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 880 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"She was hospitalized for worsening HF 6 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III, stable."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"No MI/stroke/revascularization within 3 months."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 41."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 110."
dapa-039
GT: not enough information
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + LVEF≤40% (score: 1.00)
- No exclusion criteria met
Inclusion met: 5
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 39."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP is not available in current records."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 106."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 39."
inclusion
UNKNOWN
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA III."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"NT-proBNP is not available in current records."
dapa-040
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 55."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 620 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 95 mmHg without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 55."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
dapa-041
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.47)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 44."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 910 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"LVEF 34%."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 108."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"NYHA III, stable for 6 months."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 44."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"LVEF 34%."
dapa-042
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 50."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 420 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Hospitalized for worsening HF 9 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 50."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
dapa-043
GT: excluded
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 51."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 390 pg/mL."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"A 67-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"Hospitalized for worsening HF 9 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"LVEF 39%."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 119."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 51."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"SBP 119."
dapa-044
GT: excluded
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.55)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 60-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 58."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"He had an acute myocardial infarction treated with PCI 2 months ago."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 58."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"Sinus rhythm."
dapa-045
GT: included
Included
Обоснование:
- + Male or female, aged ≥18 years (score: 1.00)
- + Established documented diagnosis of symptomatic HF... (score: 0.57)
- No exclusion criteria met
Inclusion met: 6
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female, aged ≥18 years
🏥 Из анамнеза пациента
"A 69-year-old man with chronic nonischemic HFrEF."
inclusion
MET
📋 Критерий
LVEF≤40%
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
🏥 Из анамнеза пациента
"eGFR 37."
inclusion
MET
📋 Критерий
Elevated NT-proBNP levels
🏥 Из анамнеза пациента
"NT-proBNP 660 pg/mL."
inclusion
MET
📋 Критерий
Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
🏥 Из анамнеза пациента
"SBP 102 without symptoms."
exclusion
NOT MET
📋 Критерий
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic bradycardia or second or third degree heart block without a pacemaker
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Type 1 diabetes mellitus
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
🏥 Из анамнеза пациента
"SBP 102 without symptoms."
exclusion
NOT MET
📋 Критерий
HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
🏥 Из анамнеза пациента
"eGFR 37."
inclusion
UNKNOWN
📋 Критерий
Provision of signed informed consent prior to any study specific procedures
🏥 Из анамнеза пациента
"No recent CV events."
emp-001
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF for 4 years."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL (sinus rhythm)."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF for 4 years."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"No recent MI or stroke."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 108 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 108 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 67-year-old man with chronic HFrEF for 4 years."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 28."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL (sinus rhythm)."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 28."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 32%."
emp-002
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,400 pg/mL."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,400 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 104."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 70-year-old woman with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 104."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,400 pg/mL."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA III."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 22."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 35%."
emp-004
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 750 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 750 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 without dizziness."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 without dizziness."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 750 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 60."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 40%."
emp-005
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.46)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 118."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 118."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 19."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 19."
emp-006
GT: not enough information
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.59)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF and AF."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 112."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 112."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF and AF."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,100 pg/mL with AF on ECG."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 33%."
emp-007
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 58-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"Type 2 diabetes on metformin."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"Type 2 diabetes on metformin."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 33."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
emp-008
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 41%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 124."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 124."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 920 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 54."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 41%."
emp-009
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.48)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 28%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 28%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 107."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 107."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 21."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 28%."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 28%."
emp-011
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 103."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 103."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 73-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 24."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 900 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 24."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 35%."
emp-013
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 860 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 860 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 102."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 102."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 29."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 860 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 29."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 39%."
emp-014
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Type 1 diabetes on insulin."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Type 1 diabetes on insulin."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 810 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 23."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
emp-015
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.55)
- No exclusion criteria met
Inclusion met: 9
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 74-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
inclusion
MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20 exactly on repeat labs."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 110."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 74-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 110."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20 exactly on repeat labs."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,000 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 31%."
emp-016
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 770 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 770 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 40%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 59-year-old man with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No diabetes."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 61."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 40%."
emp-017
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 790 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 41."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 37%."
emp-019
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 63-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 117."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 117."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 63-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 810 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 52."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
emp-021
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 105."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 105."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 29%."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,200 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No SGLT2 inhibitor use."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 26."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
emp-022
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 61-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 61-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 790 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 44."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 39%."
emp-023
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 102."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 102."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"LVEF 38%."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 21."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
emp-024
GT: not enough information
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.55)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 37%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 65-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP was measured 14 months ago; no recent value available."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"eGFR 58."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 58."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 37%."
emp-025
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.48)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101 without symptoms."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101 without symptoms."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,600 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 20."
emp-027
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 74-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 106."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 74-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 106."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 25."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,300 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 25."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
emp-028
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 101."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 820 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 23."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
emp-029
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 39%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 109."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 109."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 800 pg/mL."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"NYHA II."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 19."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 39%."
emp-030
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 38%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 without symptoms."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 without symptoms."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No recent CV events."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 27."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 27."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 38%."
emp-031
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"Hospitalized for worsening HF 6 months ago."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 104 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 104 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On ARNI + beta-blocker + MRA + diuretic."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 2,600 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
emp-032
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.55)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,400 pg/mL."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP 2,400 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 106."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 68-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 106."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 34."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
emp-033
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.59)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 112."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 112."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,050 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 34%."
emp-034
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.59)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 111."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 62-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 111."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 10 months ago."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
emp-035
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.50)
- No exclusion criteria met
Inclusion met: 9
Inclusion not met: 0
Unknown: 1
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 610 pg/mL."
inclusion
MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On full GDMT."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 109."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On full GDMT."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On full GDMT."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 109."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 8 months ago."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
emp-036
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.50)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"HF hospitalization 8 months ago."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 110."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 71-year-old man with ischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 110."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 8 months ago."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 28."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
emp-037
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 118."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 118."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,900 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 40."
emp-038
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
- No exclusion criteria met
Inclusion met: 10
Inclusion not met: 0
Unknown: 0
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 2,050 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"Atrial fibrillation documented."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 34%."
inclusion
MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"Atrial fibrillation documented."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 116."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 116."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 66-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 7 months ago."
emp-039
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 70-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 5 months ago."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,200 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 32%."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 114."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"eGFR 19 mL/min/1.73 m² on repeat labs."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 114."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 5 months ago."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,200 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 32%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"NYHA III."
emp-040
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 36%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 36%."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 100 mmHg at screening without clear symptoms."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 100 mmHg at screening without clear symptoms."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 63-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"SBP 100 mmHg at screening without clear symptoms."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 36%."
emp-041
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 58-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 11 months ago."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 122."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 58-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 122."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 11 months ago."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Type 1 diabetes mellitus on insulin."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Type 1 diabetes mellitus on insulin."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 700 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 30%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 30%."
emp-042
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.52)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II–III."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,150 pg/mL."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"Type 2 diabetes; he has been taking dapagliflozin for the last 3 months."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 108."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"Type 2 diabetes; he has been taking dapagliflozin for the last 3 months."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 69-year-old man with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 108."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 6 months ago."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"NYHA II–III."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 1,150 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 33%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 38."
emp-043
GT: not enough information
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 4 months ago."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 35%."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NT-proBNP value is not available in current records."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP value is not available in current records."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"HF hospitalization 4 months ago."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 115."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 115."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 72-year-old woman with chronic HFrEF."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP value is not available in current records."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA III."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 4 months ago."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"NYHA III."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 35%."
emp-044
GT: excluded
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 8
Inclusion not met: 0
Unknown: 2
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 65-year-old man with chronic HFrEF."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"His last HF hospitalization was 14 months ago with no admissions since."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 119."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"His last HF hospitalization was 14 months ago with no admissions since."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"His last HF hospitalization was 14 months ago with no admissions since."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 119."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"LVEF 29%."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"No type 1 diabetes and no SGLT2 inhibitor exposure."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Sinus rhythm."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"NT-proBNP 650 pg/mL."
inclusion
UNKNOWN
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"LVEF 29%."
inclusion
UNKNOWN
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"eGFR 41."
emp-045
GT: included
Included
Обоснование:
- + Male or female patient age >= 18 years at screenin... (score: 1.00)
- + Patients with chronic HF (Chronic Heart Failure) N... (score: 0.53)
- No exclusion criteria met
Inclusion met: 10
Inclusion not met: 0
Unknown: 0
Exclusion met: 0
Анализ критериев:
inclusion
MET
📋 Критерий
Male or female patient age >= 18 years at screening. For Japan only: Age >= 20 years at screening
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
inclusion
MET
📋 Критерий
Signed and dated written ICF (Informed Consent Form)
🏥 Из анамнеза пациента
"Will provide informed consent."
inclusion
MET
📋 Критерий
If EF >= 31% to <= 35%: NT-proBNP >= 1000 pg/ml for patients without AF and NT-proBNP >=2000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
If EF<= 30%: NT-proBNP >= 600 pg/ml for patients without AF and NT-proBNP >=1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
EF ≤ 40% and hospitalization for heart failure in the past 12 months: NTproBNP ≥ 600 pg/ml for patients without AF and NT-proBNP >= 1200 pg/ml for patients with AF
🏥 Из анамнеза пациента
"NT-proBNP 1,020 pg/mL."
inclusion
MET
📋 Критерий
If EF >= 36% to <= 40%: NT-proBNP >= 2500 pg/ml or patients without AF (atrial fibrillation/atrial flutter) and NT-proBNP >= 5000 pg/ml for patients with AF
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
inclusion
MET
📋 Критерий
Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class II-IV and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) <=40%) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide)
🏥 Из анамнеза пациента
"NYHA II."
inclusion
MET
📋 Критерий
Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines
🏥 Из анамнеза пациента
"LVEF 31%."
inclusion
MET
📋 Критерий
Further inclusion criteria apply
🏥 Из анамнеза пациента
"Will provide informed consent."
exclusion
NOT MET
📋 Критерий
Symptomatic hypotension and/or a SBP < 100 mmHg
🏥 Из анамнеза пациента
"SBP 107 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Current use or prior use of a SGLT (Sodium-glucose co-transporter)-2 inhibitor or combined SGLT-1 and 2 inhibitor
🏥 Из анамнеза пациента
"No type 1 diabetes and no prior SGLT2 inhibitor use."
exclusion
NOT MET
📋 Критерий
Acute decompensated HF
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration Equation)) or requiring dialysis
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
🏥 Из анамнеза пациента
"SBP 107 without hypotensive symptoms."
exclusion
NOT MET
📋 Критерий
Currently enrolled in another investigational device or drug study
🏥 Из анамнеза пациента
"Will provide informed consent."
exclusion
NOT MET
📋 Критерий
Heart transplant recipient, or listed for heart transplant
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
🏥 Из анамнеза пациента
"Will provide informed consent."
exclusion
NOT MET
📋 Критерий
Indication of liver disease
🏥 Из анамнеза пациента
"NYHA II."
exclusion
NOT MET
📋 Критерий
Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
🏥 Из анамнеза пациента
"A 61-year-old woman with nonischemic HFrEF."
exclusion
NOT MET
📋 Критерий
History of ketoacidosis
🏥 Из анамнеза пациента
"HF hospitalization 9 months ago."
exclusion
NOT MET
📋 Критерий
Further exclusion criteria apply
🏥 Из анамнеза пациента
"On stable GDMT."